The Pharmacovigilance and Label Management solution, addresses the pharmaceutical challenge around effectively logging and investigating safety issues and the related labeling process both quickly and accurately to avoid falling out of regulatory compliance. It assists users in navigating the safety tracking and labeling process and improves overall cycle times – as items are no longer buried in email or get stacked up waiting for meetings before they can be addressed.
Users can manage their safety reporting process as a case management solution allowing all items to be addressed in parallel before coming together in automatically generated documents that could be quickly incorporated into filings with the local health authority. In a similar fashion, with updates to their core safety information on labels, users are able to gain better penetration into understanding each country’s labeling status, as updates are cascaded down from headquarters into supporting local workflows. These workflows also bubble back up real-time updates to status, deviation, and deferral requests into a management dashboard that focuses on overall aging – giving a clear view into the current state at any time.
Key Application Highlights:
- Easy-to-use templates for user completion
- Comprehensive view for users to access information on a case-by-case basis
- Generation of audit reports for every case file
- Role-based visibility of milestones across the organization
- Automated Case Handling
- Transparency into Compliance Reporting
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